BAIXIN

GUDID 06936018500086

Anhui Kangda Medical Products Co.,Ltd.

General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle

• Primary Device ID: 06936018500086
• NIH Device Record Key: d35b88fc-977a-4ad5-bbbb-10fa24282b6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BAIXIN
• Version Model Number: 1MLLS2315
• Company DUNS: 529827552
• Company Name: Anhui Kangda Medical Products Co.,Ltd.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936018500062 [Unit of Use]
GS1	06936018500079 [Primary]
GS1	06936018500086 [Package]; Contains: 06936018500079; Package: Case [2400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083686

FDA Product Code

• FMF: Syringe, Piston

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

[06936018500086]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-21
• Device Publish Date: 2021-06-11

On-Brand Devices [BAIXIN]

• 06936018500000: 1MLLS231
• 16936018500267: 3MLLL2315
• 16936018500236: 3MLLL231
• 16936018500205: 3MLLS2515
• 16936018500175: 3MLLS251
• 16936018500144: 3MLLS2315
• 16936018500113: 3MLLS231
• 16936018500083: 1MLLL2515
• 16936018500052: 1MLLL251
• 16936018500021: 1MLLL2315
• 06936018500383: 5MLLL
• 06936018500352: 3MLLL
• 06936018500321: 1MLLL
• 06936018500291: 5MLLL251
• 06936018500260: 5MLLL231
• 06936018500239: 3MLLL2515
• 06936018500208: 3MLLL251
• 06936018500178: 1MLLL231
• 06936018500147: 1MLLS2515
• 06936018500116: 1MLLS251
• 06936018500086: 1MLLS2315
• 06936018501892: 27GSVS
• 06936018501861: 26GSVS
• 06936018501830: 25GSVS
• 06936018501809: 24GSVS
• 06936018501779: 23GSVS
• 06936018501748: 22GSVS
• 06936018501717: 21GSVS
• 06936018501687: 20GSVS
• 06936018501656: 19GSVS
• 06936018501625: 18GSVS